Pharmaceutical Polymorphs & Patent Strategy

(This article is a summary of the issues discussed in

Duncan's 21 May 2008 presentation at the Generic Medicine

Industry Association conference in Sydney Australia.)

The Glivec battle in India

Novartis's ongoing stoush with the Madras High Court in

India created quite a stir on the world stage late last year.

It concerns the patentability of the Beta crystalline form of

Imatinib, the active pharmaceutical ingredient in the

blockbuster drug (Gleevec). (For those who are unaware, polymorphs are the various crystal forms

of a material.)

The case derives from substantial changes to the Indian

Patent Act made in 2005 and focuses on section 3(d) which bars

from patentability certain types of patents which have

traditionally been quite useful to innovator companies. The

section reads:

'The following are not inventions within the

meaning of this Act,

...

'the mere discovery of a new form of a known substance

which does not result in the enhancement of the known

efficacy of that substance or the mere discovery of any new

property or new use for a known substance or of the mere use

of a known process, machine or apparatus unless such known

process results in a new product or employs at least one new

reactant.'

The case is currently mired in side issues about the

constitutionality of the section and the proper composition of

the Appeals Board which was to hear the appeal from the

original patent office decision. Please read our

August 2007 article for further background on the case.

International ramifications

One of the allegations that has been made by Novartis is

that India's section 3(d) does not comply with TRIPS. The

contrary argument (much propounded by Shamnad Basheer over at

SpicyIP) is that it does, as it is merely

an obviousness standard that member states are free to define

in a manner consistent with their national policy.

The controversy has become even more acute since a number of

other Asian countries have apparently foreshadowed that they

will enact provisions similar to India's 3(d). These

include the Philippines, Maldives, Pakistan, Sri Lanka,

Vietnam, Indonesia, Malaysia and Bangladesh.

So how are things looking in other jurisdictions?

A mixed bag...

United Kingdom criticises 'try on'

patents

On 9 May 2008, the UK Court of Appeal handed down its decision in the Perindopril

(Coversyl) beta polymorph patent case. In essence, the patent

was held to be obvious in light of a prior patent owned by the

innovator (Servier) which disclosed...